CN104055832B - A kind of Radix Astragali broken wall preparation - Google Patents
A kind of Radix Astragali broken wall preparation Download PDFInfo
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- CN104055832B CN104055832B CN201310089961.XA CN201310089961A CN104055832B CN 104055832 B CN104055832 B CN 104055832B CN 201310089961 A CN201310089961 A CN 201310089961A CN 104055832 B CN104055832 B CN 104055832B
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Abstract
The present invention relates to a kind of Chinese medicine preparation, it particularly relates to a kind of Radix Astragali broken wall preparation.Invention by the Radix Astragali by being crushed into superfine powder, further by ethanol water wet granulation, and the extrusion forming under certain rotating speed, dry, thus obtained Radix Astragali broken wall preparation has higher bioavailability, and preparation stability is strong, disintegrative is good.
Description
Technical field
The present invention relates to tcm field, more particularly, to a kind of Radix Astragali broken wall preparation.
Background technology
Superfine communication technique is the new technology developed rapidly in recent years.Active ingredient in Chinese medicine is distributed in mostly
Into the cell, it can only discharge part active ingredient when conventional medicine materical crude slice decocts, utilization rate of active components 10-30%；And use broken
Wall crushing technology, the prepared slices of Chinese crude drugs are such as crushed to 300 mesh or so, cell-wall breaking ratio is up to 86.7%, improves in medicinal material effectively
The dissolution of composition, its drug effect is greatly enhanced, utilization rate of active components reaches more than 90% and reduces medicinal material usage amount and protection medicine
Aptitude source, while can also improve the quality increase drug effect of medicine.But current main ultrastructurepower technology is remained in Chinese medicine
Material is crushed to the stage of superfine formulation.Due to the increase of superfine formulation cell-wall breaking ratio, the product increase of broken wall dosage surface, shape be present
Irregularly, mobility, bad dispersibility, it is easy to the inherent characteristicses such as moisture absorption, stability difference, is pelletized, improve the stability of product,
Preparation prepared by the present invention solves the problem present on well, reaches the utilization of medicinal material and using maximization.
At present, for following technical barrier be present in broken wall preparation and its pelletization：（1）Current broken wall preparation is use up
The utilization rate of pipe traditional Chinese medicine ingredients is high, but broken wall powder is easily oxidised, and stability is not high, and drug effect is easily lost；（2）In existing
The product that medicine kind is obtained by soft material granulation, it is difficult to ensure yield, disintegrative and stability simultaneously；（3）Some herbal species
It is not suitable for that preparation is made using broken wall powder-soft material granulation method, such as matrimony vine, radix achyranthis bidentatae etc；And the present invention is by a large amount of
It is experimental to grope, the herbal species of suitable broken wall powder-soft material granulation method are screened, and find out the bar of each step
Part.
The Radix Astragali is legume astragalus mongolicus Astragalus membranaceus (Fisch.) Bge. var.
Mongholicus (Bge.) Hsiao or Astragalus membranacus Astragalus membranaceus (Fisch.) Bge.'s is dry
Dry.Mainly contain triterpenoid saponins：Astragaloside I, II, III, IV (Astragaloside IV）, Sayasaponin Ⅰ, pod membrane Astragalosid I,
II etc.；Flavones ingredient：Onocerin, calycosin glucoside etc.；Also containing polysaccharide, amino acid etc..Decocted using traditional
Method is boiled, is easily destroyed its heat-sensitive ingredients, another aspect active ingredient decocts not exclusively, causes the loss of active ingredient.Will
The Radix Astragali is prepared into Radix Astragali superfine powder, is advantageous to improve the utilization rate of active ingredient, but simultaneously because the increasing of powder specific-surface area detection
Add, produce the shortcomings that being easy to the moisture absorption, oxidation, rotten etc..Therefore, on the basis of superfine powder is prepared into, it is also necessary to which it is entered
The further processing transformation of row, effectively to overcome these unfavorable factors, the maximized therapeutic effect for playing medicine.
The content of the invention
The technical problems to be solved by the invention are, in order to overcome Radix Astragali broken wall powder above shortcomings, there is provided one
Kind Radix Astragali broken wall preparation.
Above-mentioned technical problem to be solved by this invention is achieved by the following technical programs：
A kind of Radix Astragali broken wall preparation provided by the invention, is adopted the following technical scheme that：The Radix Astragali is carried out into broken wall crushing to obtain
Superfine powder is obtained, ethanol-water solution is added and is sufficiently mixed, softwood is made, further extruding obtains wet grain, dry to obtain the Radix Astragali
Broken wall preparation；90% or more grain diameter is less than or equal to 45 μm in the superfine powder.
Radix Astragali broken wall preparation prepared by the present invention, can cause consumer when taking without decoction, by using warm water
Take after mixing it with water and may be such that utilizing for active ingredient maximizes.
The Radix Astragali can be first crushed to 100 mesh, be further carried out ultramicro grinding so that 90% or more in superfine powder
（For example can be 90%, 91%, 92%, 93%, 94% or 95%）Grain diameter be less than or equal to 45 μm.What is used in the present invention is ultra-fine
Powder, 90% grain diameter are nearly 45 μm of powder, are more with 35 ~ 45 μm（Such as can be 35,36,37,38,39,40,
41st, 41,42,43,44 or 45 μm）But as long as it is that particle diameter is less than or equal to 45 μm of achievable present invention.
Preferably, the sporoderm-broken rate of described superfine powder is 80 ~ 95%.
The advantages of present invention carries out wet granulation using ethanol-water solution, and it is protruded is need not any other addition
Agent, you can so that the superfine powder of the present invention is pelletized, dried by follow-up, turn into formulation of astragalus root particle.But in this process,
The ethanol-water solution of which kind of concentration, and the proportioning between the solution and superfine powder should be used, is all to need strict control
Parameter, to cause the humidity of softwood, solid content, viscosity etc. to be applicable to the characteristic of Radix Astragali broken wall preparation, making can between preparation
Effectively bond；Further by the setting of specific squeezing parameter, by softwood extruding as density, sizeable radix astragali particle
Preparation, make its density/fluffy degree appropriate, thus after drying as finished product, even if being positioned in air at room temperature, can also prevent
The only oxidation of air.Also, the finished product obtained, when taking with warm water, superfine formulation can relatively quickly dissipate
Open so that active ingredient is rapid and fully dissolves and spreads, and improves utilization rate of active components.
The present invention finally have chosen following scheme by repeatedly groping：
During wet granulation, the mass fraction of ethanol is 20% ~ 80% in used ethanol-water solution；Preferably, ethanol
Mass fraction be the ﹪ of 30 ﹪~70, the ﹪ of more preferably 45 ﹪~65.When ethanol mass fraction is 20% ~ 29%, superfine powder
Body is with ethanol-water solution than 1 ︰ 0.6 ~ 0.65 by weight, preferably 1 ︰ 0.6；When ethanol mass fraction is 30% ~ 39%,
Superfine powder is with ethanol-water solution than 1 ︰ 0.6 ~ 0.9 by weight, preferably 1 ︰ 0.6 ~ 0.65；When ethanol mass fraction is
When 40% ~ 49%, superfine powder is with ethanol-water solution than 1 ︰ 0.6 ~ 1.0 by weight, preferably 1 ︰ 0.6 ~ 0.7；When ethanol matter
When amount fraction is 50% ~ 59%, superfine powder is with ethanol-water solution than 1 ︰ 0.6 ~ 1.1 by weight, preferably 1 ︰ 0.6 ~ 0.8；
When ethanol mass fraction is 60% ~ 69%, superfine powder is with ethanol-water solution than 1 ︰ 0.6 ~ 1.2 by weight, preferably 1 ︰
0.8 ~ 1.0, when ethanol mass fraction is 70% ~ 80%, superfine powder and ethanol-water solution than 1 ︰ 0.6 ~ 1.3 by weight,
Preferably 1 ︰ 0.8 ~ 1.1.
When softwood extruding is turned into wet grain, following condition is preferably controlled in：Using the prepackage eye mesh screen of 10 mesh~30, squeeze
Surging 0.05Mpa~1Mpa, rotating speed 50r/min~100r/min；Preferably, dynamics 0.7Mpa~0.8Mpa, rotating speed are extruded
55r/min~65r/min.
The wet grain particle diameter of extruding gained is the mesh of 14 mesh ~ 30, and drying temperature is 45 DEG C ~ 85 DEG C when drying, and drying time is
0.5h~4.0h。
The heap density of the Radix Astragali broken wall preparation obtained is 0.30g/ml~0.65g/ml.
Compared with prior art, the invention has the advantages that：
（1）The formulation of astragalus root obtained by the method for the present invention, its utilization rate of active components greatly improve, and utilization rate approaches
In 100%；Being tested through bioequivalence confirms, can be equivalent to the drug effect of 1 part of traditional Radix Astragali using 1/4 part of Radix Astragali broken wall preparation；
（2）The present invention is by groping to obtain suitable wet granulation technology so that pelletization is except the addition of alcohol-water
Outside, do not introduce other any additives, you can solid content, the softwood of modest viscosity are obtained, to be successfully squeezed into
Grain technique, the Chinese medicinal granule stability formed is strong, is not easy to collapse in storage and transportation rotten；
（3）The extruding condition of the present invention has groped suitable rotating speed and extruding force, and stickiness, the Huang of medium density is thus made
Stilbene granular preparation, while acquisition finished product stability is strong, it is easily disintegrated again during taking scattered, be easy to warm water to rush
Clothes.
Embodiment
In order to be more clearly understood that the technology contents of the present invention, described in detail especially exemplified by following examples, but the present invention
Embodiment not limited to this.
Embodiment 1
The net medicinal material of the Radix Astragali is taken, after coarse powder is broken to 100 mesh or so coarse powder, through ultramicro grinding into superfine powder 90%
Grain particle diameter is less than or equal to 45 μm of powder, adds ethanol-water solution（Ethanol mass fraction is 20%）Wet method softwood, solution with
Superfine powder addition is than 0.6 ︰ 1（By weight）, after mixing, through pre-installing 10 mesh sieves, from extruding rotating speed 50r/min, extruding
Dynamics 1MPa wet granulars, in wet granular transposition heated-air circulation oven, 85 DEG C of drying temperature is set, dry 2.5h to dry, whole grain
Radix Astragali broken wall preparation is produced after screening.
Remarks：Full marks are in terms of 10.
Embodiment 2
The net medicinal material of the Radix Astragali is taken, after coarse powder is broken to 100 mesh or so coarse powder, through ultramicro grinding into superfine powder 90%
Grain particle diameter is less than or equal to 45 μm of powder, adds ethanol-water solution（Ethanol mass fraction is 40%）Wet method softwood, solution with
Superfine powder addition is than 0.9 ︰ 1（By weight）, after mixing, through pre-installing 10 mesh sieves, from extruding rotating speed 70r/min, extruding
Dynamics 0.9MPa wet granulars, in wet granular transposition vacuum microwave drying case, 45 DEG C of drying temperature is set, dries 0.75h to dry,
Radix Astragali broken wall preparation is produced after whole grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 3
The net medicinal material of the Radix Astragali is taken, after coarse powder is broken to 100 mesh or so coarse powder, through ultramicro grinding into superfine powder 90%
Grain particle diameter is less than or equal to 45 μm of powder, adds ethanol-water solution（Ethanol mass fraction is 60%）Wet method softwood, solution with
Superfine powder addition is than 1.0 ︰ 1（By weight）, after mixing, through pre-installing 30 mesh sieves, from extruding rotating speed 80r/min, extruding
Dynamics 0.3MPa wet granulars, in wet granular transposition heated-air circulation oven, 85 DEG C of drying temperature is set, dry 2.5h to dry, it is whole
Radix Astragali broken wall preparation is produced after grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 4
The net medicinal material of the Radix Astragali is taken, after coarse powder is broken to 100 mesh or so coarse powder, through ultramicro grinding into superfine powder 90%
Grain particle diameter is less than or equal to 45 μm of powder, adds ethanol-water solution（Ethanol mass fraction is 80%）Wet method softwood, solution with
Superfine powder addition is than 1.1 ︰ 1（By weight）, after mixing, through pre-installing 30 mesh sieves, from extruding rotating speed 60r/min, extruding
Dynamics 0.6MPa wet granulars, in wet granular transposition vacuum microwave drying case, 50 DEG C of drying temperature is set, dries 0.5h to dry,
Radix Astragali broken wall preparation is produced after whole grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 5
Take the net medicinal material of the Radix Astragali, after coarse powder is broken to 100 mesh or so coarse powder, be ground into through ultramicro grinding 90% in superfine powder
Grain diameter be less than or equal to 45 μm of powder, add ethanol-water solution（Second mass fraction is 70%）Wet method softwood, solution
With superfine powder addition than 0.8 ︰ 1（By weight）, after mixing, through pre-installing 20 mesh sieves, from extruding rotating speed 100r/min, squeeze
Surging 0.05MPa wet granulars, in wet granular transposition heated-air circulation air box, 70 DEG C of drying temperature is set, dries 2.0h to dry,
Radix Astragali broken wall preparation is produced after whole grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 6
Take the net medicinal material of the Radix Astragali, after coarse powder is broken to 100 mesh or so coarse powder, be ground into through ultramicro grinding 90% in superfine powder
Grain diameter be less than or equal to 45 μm of powder, the mass fraction for adding ethanol-water solution is 40% solution wet method softwood,
Solution is with superfine powder addition than 1.1 ︰ 1（By weight）, after mixing, through pre-installing 20 mesh sieves, from extruding rotating speed 80r/
Min, dynamics 0.2MPa wet granulars are extruded, using fluidized drying, set and dry 85 DEG C of EAT, dry 1.0h to dry, it is whole
Radix Astragali broken wall preparation is produced after grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 7
The net medicinal material of the Radix Astragali is taken, after coarse powder is broken to 100 mesh or so coarse powder, through ultramicro grinding into superfine powder 90%
Grain particle diameter is less than or equal to 45 μm of powder, adds ethanol-water solution（Ethanol mass fraction is 20%）Wet method softwood, solution with
Superfine powder addition is than 0.7 ︰ 1（By weight）, after mixing, through pre-installing 10 mesh sieves, from extruding rotating speed 50r/min, extruding
Dynamics 1MPa wet granulars, in wet granular transposition heated-air circulation oven, 85 DEG C of drying temperature is set, dry 2.5h to dry, whole grain
Radix Astragali broken wall preparation is produced after screening.
Remarks：Full marks are in terms of 10.
Embodiment 8
Take the net medicinal material of the Radix Astragali, after coarse powder is broken to 100 mesh or so coarse powder, be ground into through ultramicro grinding 90% in superfine powder
Grain diameter be less than or equal to 45 μm of powder, the mass fraction for adding ethanol-water solution is 30% solution wet method softwood,
Solution is with superfine powder addition than 0.65 ︰ 1（By weight）, after mixing, through pre-installing 20 mesh sieves, from extruding rotating speed 65r/
Min, dynamics 0.7MPa wet granulars are extruded, using fluidized drying, set and dry 85 DEG C of EAT, dry 1.0h to dry, it is whole
Radix Astragali broken wall preparation is produced after grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 9
Take the net medicinal material of the Radix Astragali, after coarse powder is broken to 100 mesh or so coarse powder, be ground into through ultramicro grinding 90% in superfine powder
Grain diameter be less than or equal to 45 μm of powder, the mass fraction for adding ethanol-water solution is 50% solution wet method softwood,
Solution is with superfine powder addition than 0.8 ︰ 1（By weight）, after mixing, through pre-installing 20 mesh sieves, from extruding rotating speed 85r/
Min, dynamics 0.5MPa wet granulars are extruded, using fluidized drying, set and dry 85 DEG C of EAT, dry 1.0h to dry, it is whole
Radix Astragali broken wall preparation is produced after grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 10
The net medicinal material of the Radix Astragali is taken, after coarse powder is broken to 100 mesh or so coarse powder, through ultramicro grinding into superfine powder 90%
Grain particle diameter is less than or equal to 45 μm of powder, adds ethanol-water solution（Ethanol mass fraction is 80%）Wet method softwood, solution with
Superfine powder addition is than 1.3 ︰ 1（By weight）, after mixing, through pre-installing 30 mesh sieves, from extruding rotating speed 50r/min, extruding
Dynamics 0.8MPa wet granulars, in wet granular transposition vacuum microwave drying case, 50 DEG C of drying temperature is set, dries 0.5h to dry,
Radix Astragali broken wall preparation is produced after whole grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 11
The net medicinal material of the Radix Astragali is taken, after coarse powder is broken to 100 mesh or so coarse powder, through ultramicro grinding into superfine powder 90%
Grain particle diameter is less than or equal to 45 μm of powder, adds ethanol-water solution（Ethanol mass fraction is 80%）Wet method softwood, solution with
Superfine powder addition is than 1.3 ︰ 1（By weight）, after mixing, through pre-installing 30 mesh sieves, from extruding rotating speed 70r/min, extruding
Dynamics 1.0MPa wet granulars, in wet granular transposition vacuum microwave drying case, 50 DEG C of drying temperature is set, dries 0.5h to dry,
Radix Astragali broken wall preparation is produced after whole grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 12
Take the net medicinal material of the Radix Astragali, after coarse powder is broken to 100 mesh or so coarse powder, be ground into through ultramicro grinding 90% in superfine powder
Grain diameter be less than or equal to 45 μm of powder, the mass fraction for adding ethanol-water solution is 25% solution wet method softwood,
Solution is with superfine powder addition than 0.65 ︰ 1（By weight）, after mixing, through pre-installing 20 mesh sieves, from extruding rotating speed 100r/
Min, dynamics 0.03MPa wet granulars are extruded, using fluidized drying, set and dry 85 DEG C of EAT, dry 1.0h to dry, it is whole
Radix Astragali broken wall preparation is produced after grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 13
1 ~ 5,8 ~ 9 lower finished product of Example presses final product quality standard test, as a result meets Chinese Pharmacopoeia correlation formulation
Regulation requires under, as a result as shown in table 1.
Further by embodiment 1 ~ 5,8 ~ 9 lower Radix Astragali broken wall preparation and Radix Astragali superfine powder, Radix Astragali routine medicine materical crude slice, with property
Shape, moisture and active ingredient Astragaloside IV are placed on temperature 40 as evaluation index, three after being encapsulated using sealed plastic bag
DEG C ± 2 DEG C, each preparation stability is evaluated after being placed 30 days, 60 days, 90 days under conditions of relative humidity 75% ± 5%.As a result
Such as following table：
As can be seen from the above table, moisture is very steady in different times in the Radix Astragali broken wall preparation that the present invention is prepared
It is fixed, and the moisture in Radix Astragali ultrafine powder changes greatly in different times, illustrates that Radix Astragali ultrafine powder hygroscopicity is stronger.By
In the easy moisture absorption of Radix Astragali ultrafine powder so that easy breed bacteria in ultrafine powder, it can so cause active ingredient to accelerate to decompose, on
The content decline of Astragaloside IV also demonstrates Radix Astragali superfine powder active ingredient and easily decomposed in table.It is made when using the inventive method
After Radix Astragali broken wall preparation, wherein moisture is sufficiently stable, it is not easy to which moisture absorption, compared with Radix Astragali superfine powder, its stability is big
It is big to improve.
Embodiment 14
Another step is made by acute toxicity and the advance of the drug effect contrasts description of test present invention, Example 3 below
Formulation of astragalus root compared with traditional medicine materical crude slice.
First, acute toxicity test
KM kind mouse, 60, male and female half and half, it is randomly divided into control group, Radix Astragali routine medicine materical crude slice group（32g/kg body weight）, the Radix Astragali
Broken wall preparation group（32g/kg body weight）.
Table 1,2 results show that Radix Astragali routine medicine materical crude slice, Radix Astragali broken wall preparation are 32g/ to mouse stomach maximum dosage-feeding on the one
Kg body weight, equivalent to 64 times of quantity, produced without obvious acute toxicity.
The result of table 2 shows that Radix Astragali broken wall preparation group, each organ index of Astragalus membranaceus group animal are compared with control group
Difference that there are no significant（P ＞ 0.05）.
2nd, pharmacodynamics compares
SPF level KM kind mouse are taken, male and female half and half, body weight 18-22g, are randomly divided into Normal group, model control group, life
Arteries and veins Capsules group, Radix Astragali tradition medicine materical crude slice group（Traditional decoction mode, gavage）, Radix Astragali broken wall preparation 0.25g/kg groups, Radix Astragali broken wall system
Agent 0.5g/kg groups, Radix Astragali broken wall preparation 1.0g/kg groups, Radix Astragali broken wall preparation 2.0g/kg groups, every group 10.Broken wall preparation
Group is after preparation made from embodiment 3 is placed 90 days, to be reconstituted with 60 ° or so of warm water, take supernatant gastric infusion.
Table 3,4 results show that the drug action of Radix Astragali wall cell disruption powder is better than Radix Astragali routine medicine materical crude slice, equivalent to 1/8 amount.
Claims (1)
1. a kind of Radix Astragali broken wall preparation, it is characterised in that be prepared by following steps：The net medicinal material of the Radix Astragali is taken, is broken to through coarse powder
After 100 mesh coarse powder, in superfine powder 90% powder of the grain diameter less than or equal to 45 μm is ground into through ultramicro grinding, adds second
The mass fraction of alcohol-water solution is 30% solution wet method softwood, and solution adds weight than 0.65 ︰ 1 with superfine powder, mixed
Afterwards, through pre-installing 20 mesh sieves, from extruding rotating speed 65r/min, dynamics 0.7MPa wet granulars are extruded, using fluidized drying, setting
85 DEG C of EAT is dried, 1.0h is dried to doing, Radix Astragali broken wall preparation is produced after whole grain screening.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310089961.XA CN104055832B (en) | 2013-03-20 | 2013-03-20 | A kind of Radix Astragali broken wall preparation |
| TW103110194A TWI531387B (en) | 2013-03-20 | 2014-03-19 | A preparation method of astragalus breaking preparation |
| HK15101620.9A HK1201161A1 (en) | 2013-03-20 | 2015-02-13 | A preparation of ultra-fine granulated powder of astragali radix |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201310089961.XA CN104055832B (en) | 2013-03-20 | 2013-03-20 | A kind of Radix Astragali broken wall preparation |
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| CN104055832A CN104055832A (en) | 2014-09-24 |
| CN104055832B true CN104055832B (en) | 2018-03-16 |
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| CN106265870A (en) * | 2016-08-08 | 2017-01-04 | 湖南盟合投资管理有限公司 | The preparation method of Radix Astragali breaking cellular wall decoction pieces |
| CN106265873A (en) * | 2016-08-25 | 2017-01-04 | 刘根喜 | A kind of Radix Astragali pure powder tablet and preparation method thereof |
| CN106924291B (en) * | 2017-03-28 | 2020-11-03 | 王全理 | Treatment method for mineral medicine or shell type traditional Chinese medicine |
| CN108310056B (en) * | 2018-04-25 | 2020-11-03 | 中山市中智药业集团有限公司 | Preparation method of no-additive traditional Chinese medicinal material wall-broken powder granular preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101147746B (en) * | 2006-09-18 | 2011-02-16 | 中山市中智药业集团有限公司 | Method for processing traditional Chinese herbs broken wall powder |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101147746B (en) * | 2006-09-18 | 2011-02-16 | 中山市中智药业集团有限公司 | Method for processing traditional Chinese herbs broken wall powder |
Non-Patent Citations (1)
| Title |
|---|
| "红参、黄芪、三七三味中药的饮片、破壁粉体、破壁粉粒的质量评价研究";刘敏;《中国优秀硕士学位论文全文数据库 医药卫生科技辑2011年第10期》;20111015;E057-6，参见正文第67页第1段 * |
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| TW201436818A (en) | 2014-10-01 |
| TWI531387B (en) | 2016-05-01 |
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| CN104055832A (en) | 2014-09-24 |
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